510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2187 of 3531

510(k) clearances, page 2187 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931016	Jace Model H440 Hand Cpm Device	Jace Systems, Inc.	JFA	Class I	1994-06-22
K926102	Phoenix Opti-Max Dent Implant W/plasma-Spray Titan	Phoenix Dental, Inc.	DZE	Class II	1994-06-22
K924589	Restore Self Tapping Dental Implant System	Implant Support Systems, Inc.	DZE	Class II	1994-06-22
K942414	Trocar Sleeve, Sealing Caps, Reducer, Loop Guide	Linvatec Corporation	GCJ	Class II	1994-06-21
K941900	Powdered Latex Exam Gloves	TG Medical Sdn Bhd	LYY	Class I	1994-06-21
K941451	Mrg Powder Free Latex Examination Gloves	M.R.G. Industries Sdn. Bhd.	LYY	Class I	1994-06-21
K941419	Disposable Spinal Introducer Sheath	Trimedyne, Inc.	GEX	Class II	1994-06-21
K941240	Dr. Boo Powder-Free Latex Exam Gloves	Dr. Boo Co., Ltd.	LYY	Class I	1994-06-21
K940682	Axsym(tm) Quinidine	Abbott Medical	LGI	Class II	1994-06-21
K940596	Axsym Phenobarbital	Abbott Medical	LGQ	Class II	1994-06-21
K940595	Axsym Vancomycin	Abbott Medical	LEH	Class II	1994-06-21
K940505	Articulating Laparoscopic Retracotor (Uresil)	Uresil, LLC	HET	Class II	1994-06-21
K940364	Magnetic Resonance Diagnostic Accessory	Medical Advances, Inc.	LNH	Class II	1994-06-21
K935946	Powder Free Latex Examination Gloves	Cranberry (M) Sdn. Bhd.	LYY	Class I	1994-06-21
K935924	Axsym Ck-Mb	Abbott Medical	JHW	Class II	1994-06-21
K935847	Axsym Ferritin	Abbott Medical	DBF	Class II	1994-06-21
K935837	Airhythm Healthcare Bed	Healthcare Designs	FNL	Class II	1994-06-21
K935675	Axsym Prolactin	Abbott Medical	CFT	Class I	1994-06-21
K935673	Axsym Total B-Hcg	Abbott Medical	JHI	Class II	1994-06-21
K935612	Axsym Follicle Stimulating Hormone (Fsh)	Abbott Medical	CGJ	Class I	1994-06-21
K935611	Axsym Luteinizing Hormone (Lh)	Abbott Medical	JJX	Class I	1994-06-21
K935376	Axsym Gentamicin	Abbott Mfg., Inc.	LCD	Class II	1994-06-21
K935375	Axsym Phenytoin Assay	Abbott Medical	LGR	Class II	1994-06-21
K935374	Axsym Carbamazephine	Abbott Medical	KLT	Class II	1994-06-21
K935373	Axsym Theophylline	Abbott Medical	KLS	Class II	1994-06-21
K934911	Saphire Plus Surgical Mirror	San Diego Swiss Machining, Inc.	EQH	Class I	1994-06-21
K934835	Floval	Olympus Corp.	FJL	Class II	1994-06-21
K934582	Gdlh Variable Angle Connector	Danek Group, Inc.	KWP	Class II	1994-06-21
K934544	Axsym Free Thyroxine ( Free T4 )	Abbott Medical	CEC	Class II	1994-06-21
K934517	Axsym Total T3	Abbott Medical	CDP	Class II	1994-06-21
K934514	Catch and Hold Option for Instascan	Advanced Nmr Systems, Inc.	LNH	Class II	1994-06-21
K934410	Axsym Ultrasensitive Htsh	Abbott Medical	JLW	Class II	1994-06-21
K934384	Axsym(tm) Total T4	Abbott Medical	CDX	Class II	1994-06-21
K934312	Axsym(tm) T-Uptake	Abbott Medical	KHQ	Class II	1994-06-21
K934205	Search-Sonic	Altana, Inc.	IYO	Class II	1994-06-21
K933729	Assure Self Sealing Sterilization Pouch	Sultan Chemists, Inc.	KCT	Class II	1994-06-21
K932883	Optilase Model 1000-100 Nd: Yag Laser System	Trimedyne, Inc.	GEX	Class II	1994-06-21
K932632	Chakoff Endoscopy Laparoscopic Instrumentation	Stephen Chakoff, Inc.	GEI	Class II	1994-06-21
K942329	Hand Controlled Syringe	Abbott Medical	DQO	Class II	1994-06-20
K942006	Interacoustics Diagnostic Audiometer	Precision Acoustics Ind., Inc.	EWO	Class II	1994-06-20
K941561	Forte US	Chattanooga Group, Inc.	IMG	Class II	1994-06-20
K936036	Karl Storz Instruments for Bipolar Coagulation	Karl Storz Endoscopy-America, Inc.	GEI	Class II	1994-06-20
K936003	Affinity Cvr	Avecor Cardiovascular, Inc.	DTN	Class II	1994-06-20
K933611	The Bte Ws30	Baltimore Therapeutic Equipment Co.	ISD	Class II	1994-06-20
K932894	620Csr Display Driver	Vidco, Inc.	DXJ	Class II	1994-06-20
K942236	Audina Prewires (Faceplate Hearing Aid Series)	Audina Hearing Instrument, Inc	LRB	Class I	1994-06-17
K942213	Optima with Delta Amp	Beltone Electronics Corp.	ESD	Class I	1994-06-17
K942164	Philips 61 Series	Philips Hearing Instruments Co.	ESD	Class I	1994-06-17
K941919	Oktas Endoscopy Video Camera System	Oktas	FET	Class II	1994-06-17
K941463	Spectacle Frames, Reading Glasses	Well Arts Optical Factory, Ltd.	HQZ	Class I	1994-06-17